US Pharm. 2010;35(12):8.Gaithersburg, MD--The FDA has approved Halaven (eribulin mesylate) for the treatment of patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease. The chemotherapeutic injectable's safety and effectiveness were established in a single study of 762 women with breast cancer. The median overall survival for patients receiving the drug was 13.1 months compared with 10.6 months for those who received a single-agent therapy. According to Richard Pazdur, MD, director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research, “There are limited treatment options for women with aggressive forms of late-stage breast cancer who have already received other therapies…Halaven shows a clear survival benefit and is an important new option for women.” The drug is marketed by Eisai Inc.
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